Prostate Cancer Clinical Trial
— PRIMARY2Official title:
Prospective Multi-centre Randomised Trial of the Additive Diagnostic Value of PSMA PET in Men With Negative/Equivocal MRI in the Diagnosis of Significant Prostate Cancer
NCT number | NCT05154162 |
Other study ID # | 20/043 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2, 2022 |
Est. completion date | March 2028 |
This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI
Status | Recruiting |
Enrollment | 660 |
Est. completion date | March 2028 |
Est. primary completion date | March 2027 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must meet all the following criteria for study entry: 1. Males aged = 18 years at the time of consent 2. No previously diagnosed prostate cancer 3. No previous prostate biopsy 4. Having undergone MRI within 9 months prior to randomisation and meet one of the following criteria: - PI-RADS 2 AND =1 red flag defined as: - PSA density >0.1 - Abnormal DRE - Strong family history (1 first degree relative or =2 second degree) - BRCA mutation - PSA >10 - PSA doubling time <36 months - PSA velocity >0.75/year - PI-RADS 3 5. Intention for prostate biopsy 6. Willing and able to comply with all study requirements Exclusion Criteria: - Patients who meet any of the following criteria will be excluded from study entry: 1. Having a PSA >20ng/ml 2. Having = cT3 on DRE 3. Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Royal Brisbane and Women's Hospital | Brisbane | Queensland |
Australia | Austin Health | Melbourne | Victoria |
Australia | Cabrini Health | Melbourne | Victoria |
Australia | Peter MacCallum Cancer Centre | Melbourne | Victoria |
Australia | St Vincent's Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Peter MacCallum Cancer Centre, Australia | St Vincent's Hospital, Sydney |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of sPCa on prostate biopsy | sPCa defined as Gleason score 3+4(>10%)=7, Grade group 2 Patients without biopsy (negative PSMA PET) are considered not to have sPCa. | When histology results are available, at an expected average of 14 days post-biopsy | |
Primary | Number of men who avoid transperineal prostate biopsy in the experimental arm | In the experimental arm, if PSMA PET is negative, the patient does not have biopsy | When the PSMA PET result is available, at most 28 days after randomisation | |
Secondary | Presence of insignificant prostate cancer (isPCa) on prostate biopsy | isPCa defined as GS 3+3=6, GG 1 or GS 3+4(=10%)=7, GG 2 | Within 3 months following randomisation | |
Secondary | Cost per quality adjusted life year | cost-effectiveness analysis to assess the cost per quality adjusted life year (QALY) gained associated with the use of PSMA PET in addition to MRI compared with MRI alone for the diagnosis of sPCa. Importantly, this analysis will take into consideration the impact on costs and QoL associated with the hypothesised reduction in unnecessary biopsies arising from the improved accuracy of PSMA+MRI and the comparative interventions). | Through study completion, estimated up to 2 years | |
Secondary | Health-related quality of life as measured by the EORTC QLQ-C30. | Quality of life (QoL) will be assessed using QLQ-C30, which contains 30 items across five functional scales, three symptom scales, global health status, and six single items. Participant responses are collected using a four-point response scale ranging from 'Not at all' to "Very much". Higher scores indicate better QoL and function, while high scores for the symptom scale represent a high level of symptoms. | Within 7 days of randomisation and every 6 months ± 30 days after randomisation | |
Secondary | Anxiety as measured by the GAD7 in the diagnosis of PCa. | The generalized anxiety disorder Scale (GAD-7)14 is a 7-item, patient-rated questionnaire for screening and severity measuring of generalised anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. | Within 7 days following randomisation and every 6 months ± 30 days after randomisation | |
Secondary | Cancer worry in the diagnosis of PCa. | The modified Cancer Worry Scale adaptation of Cancer Worry Scale is a 3-item questionnaire used in context of cancer worry in abnormal PSA levels in men participating in community screening program. The score is calculated by assigning scores of 1, 2, 3, and 4, to the categories 'not at all or rarely', 'sometimes', 'often', and 'a lot', respectively, and adding together the scores for the 3 questions. A final question asks about feelings of distress related to cancer risk. | Within 7 days following randomisation and every 6 months ± 30 days after randomisation | |
Secondary | Number of biopsy cores | Experimental arm: For patients with a positive PSMA PET, the images, the report and a simplified template will be made available to the treating urologist. Up to four identified lesions on PSMA PET and/or MRI will be targeted with each lesion having a minimum 5 cores. Control arm: Transperineal template prostate biopsies will be performed as per treating urologist's usual practice. No specific template for biopsy is prescribed for the purposes of the study. However, template sampling of the prostate is required, with a minimum of 12 cores,dependent on prostate volume. |
Within 3 months following randomisation | |
Secondary | Incidence of complications following transperineal prostate biopsy. | Complications following biopsy will be assessed with a modified questionnaire validated in the PRECISION trial. Part 1 following randomisation is a 9 item questionnaire. Part 2 is a 23 item questionnaire administered at 3 and 6 months to assess complications from transperineal prostate biopsy. The following complications will be assessed via these forms: fever, blood in urine, blood in semen, blood in stool, acute urinary retention, erectile dysfunction, urinary incontinence, urinary tract infection and pain in the perineum. | Within 7 days following randomisation and at 3 and 6 months after randomisation | |
Secondary | Incidence of erectile dysfunction following transperineal prostate biopsy | The Sexual Health Inventory for Men (SHIM) is an adapted version of the 5 item International Index of Erectile Function (IIEF-5) score, developed to diagnose the presence and severity of erectile dysfunction. This validated questionnaire has a range of scores from 1 to 25, grading erectile dysfunction into 5 categories (none, mild, mild to moderate, moderate and severe). | Within 7 days following randomisation and at 3 and 6 months after randomisation | |
Secondary | Number of men who have sPCa detected only with PSMA PET (MRI PI-RADS 2) | Measured in the experimental arm in patients with positive PSMA PET and negative MRI (PIRADS 2). sPCa defined as Gleason score 3+4(>10%)=7, Grade group 2 | Within 28 days following randomisation |
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